30/31 October 2023
In a recent Warning Letter, the FDA criticises, among other things, an inadequate training system. How does one respond to such an inspection deficiency?
During a GMP inspection by the FDA, deficiencies are noted on a form with the number 483. This "483" is then given to the inspected firm at the end of the inspection. The firm must then respond to this 483 in a timely manner and identify corrective actions. Timely usually means 15 working days, and the remedial actions should also be given time limits. If these responses are insufficient, the FDA issues a Warning Letter.
In this case, it concerns a contract laboratory. One deficiency was that the Quality Unit had not established an adequate CGMP-compliant training system. Since the Quality Unit is addressed here, the deficiency was cited under 21 CFR 211.22. Furthermore, basic GMP violations were still found.
In the contract laboratory's response to the 483, the company agrees to hire a GMP consultant to develop a GMP training programme and perform quality assurance functions. So far so good. However, the FDA criticises that there is supposed to be training in accordance with 21 CFR 820. These are the CGMP (Quality System) rules for medical devices, and the contract laboratory works in the pharmaceutical sector. The FDA therefore requires GMP training on drugs. Although the company has already mentioned that it wants to hire a consultant, the FDA also recommends this, with reference to 21 CFR 34.
Conclusion: Responses to GMP deficiencies should be made as promptly as possible and should address the remedial actions precisely in terms of content.
For more information, please see the FDA's Warning Letter to Sure-Biochem Laboratories.